Kornimate/medical-research-clean huggingface dataset:
continuous glucose monitoring (cgm) after surgical variations of the roux-en-y gastric bypass

Conditions: Continuous Glucose Monitoring; Roux-en-y Gastric Bypass; Hypoglycemia

Summary: this study evaluates the difference in post prandial tissue glucose levels between two variation of roux-en-y gastric bypass by continuous glucose monitoring.


Eligibility criteria:
inclusion criteria: 1. patients who underwent bariatric-metabolic surgery at the medical university of vienna in the years 2012-2016 for the "long and narrow" pouch group 2. patients who underwent bariatric-metabolic surgery at the clinic of hollabrunn in the years 2010- 2012 for the "short and wide" pouch group 3. patients on oral medication for diabetes mellitus (for subgroup assessment) 4. stable weight (not more than + 15kg from lowest weight postoperatively) 5. stable bmi exclusion criteria: 1. unable to give written informed consent 2. patients with methods other than rygb 3. reoperation within the observed period 4. any intervention changing pouch size or diameter of the anastomosis after the initial operation 5. known allergy to oral contrast agent 6. any regular intake of medication interfering with blood glucose levels

Keywords: metabolic surgery
efficiency and safety study of pamidronate in inflammatory back pain due to degenerative disk disease

Conditions: Intervertebral Disc Degeneration; Modic I Discopathy; Back Pain; Low Back Pain; Magnetic Resonance Imaging (MRI)

Summary: the purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as modic type 1 changes

erosive degenerative disk disease, also known as modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. intravenous pamidronate has proven effective in patients with ankylosing spondylitis, and in painful bone diseases in general. we therefore hypothesized that pamidronate would be effective in treating back pain associated with modic type 1 changes. this study aimed to determine pamidronate's efficiency in reducing pain, with the primary outcome being a between-group difference of 30 points on a 100mm vas at 3 months. secondary outcomes are the improvement in functional status and the drug's tolerance. primary and secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months, and 6 months). if the primary goal is not attained, a rigid or semi-rigid back brace will be proposed to the patient, regardless of the treatment group. in total, 48 patients will need to be recruited. these patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo. pamidronate will be administered at a dose of 90mg per day, 2 days in a row, and every patient, regardless of the treatment group, will be given paracetamol, in order to maintain blinding by preventing drug-induced fever.

Eligibility criteria:
inclusion criteria: * - age from 18 to 60 years old * low back pain * daily pain since at least 3 months * vas for pain \> 40/100 during the last 48 hours * inefficiency, intolerance, or contraindication to nsaids * inefficiency of a rigid or half-rigid back brace * modic 1 discopathy (diagnosed on mri and confirmed by trained radiologist) * dental check-up within the last 6 months * signed informed consent exclusion criteria: * - static disorders of the spine * contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy) * underage patients, patients under the protection of the law * previous treatment with bisphosphonates * pregnancy * local or general infection * previous discal surgery * systemic corticosteroid therapy in the last month * epidural or facet joint corticosteroid injection in the last month * history of septic spondylodiscitis * ankylosing spondylitis * low back pain associated with radiculalgia * active psychiatric disorder * inability to read or understand french * body temperature above 38°c (fever) or erythrocyte sedimentation rate above 20mm/hour

Keywords: modic changes chronic low back pain pamidronate magnetic resonance imaging vertebrae intervertebral disc
intrinsic peep during mechanical ventilation of patients with obesity

Conditions: General Anesthesia; Laparoscopic Cholecystectomy

Summary: it is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (peep) is present in grossly obese subjects especially in the supine position. the investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic peep and gas exchange for obese subjects undergoing general anesthesia.

impaired gas exchange is a common anesthetic problem in obese subjects. it is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (peepi) is present in grossly obese subjects especially in the supine position. it is known that there is a significant negative correlation between peepi present and pao2. therefore, the investigators postulated that if the reduce the peepi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve. the investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic peep and gas exchange for obese subjects undergoing general anesthesia.

Eligibility criteria:
inclusion criteria: * asa class i or ii obesity, body-mass index \> 27.5 undergoing laparoscopic cholecystectomy exclusion criteria: * patients with severe cardiopulmonary disease peak inspiratory pressure \> 40 in the study setting

Keywords: intrinsic positive end-expiratory pressure obesity ventilator setting respiratory rate
cerebral pulsatility index compared to mean arterial blood pressure guided protocol in sepsis induced encephalopathy:

Conditions: Sepsis; Norepinephrine; Encephalopathy

Summary: the aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.

sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. it appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * must had clinical diagnosis of sepsis induced encephalopathy. exclusion criteria: * refusal to participate in the study. * cerebral infection. * known cerebral lesions (neoplasm, traumatic brain injury, stroke, ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure). * known severe carotid stenosis (\>70％). * intoxication due to drugs. * pregnancy. * patients supported by intra-aortic balloon pumb (iabp).
effect of hsv-2 suppressive therapy on sexual behavior

Conditions: Genital Herpes

Summary: the purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (hsv) who have multiple sex partners. study terminated; investigator relocated and study funding ended. results were never analyzed because data were not collected.

we plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. we will enroll 500 hsv-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital herpes, and prospectively follow them for 1 year to assess sexual behavior, adherence to therapy, and herpes-related quality of life. these outcomes will be measured by self-report in a confidential, computer-based assessment. we plan to use data from this trial to model the effect that increasing the proportion of sexually-active hsv-2 infected persons taking suppressive therapy will have on population-level incidence and prevalence of hsv-2.

Eligibility criteria:
inclusion criteria: * age 18 years or older * hsv-2 seropositive by western blot or documented culture positive for hsv-2 from anogenital site * 2 or more vaginal or anal sex partners in the past 12 months * not currently in a monogamous sexual relationship of \>= 6 months duration * willing and able to be randomized and comply with the study protocol exclusion criteria: * pregnancy or intention to become pregnant within the next year * suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization * 6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months * hiv seropositive or known immunocompromising medical condition. hiv negative test must be performed within 60 days of visit 1 (enrollment/randomization). for current or former participants in hiv vaccine clinical trials for whom hiv vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the seattle hvtu documenting that the participant is hiv uninfected based on hiv testing done within 60 days of visit 1 will be accepted in lieu of hiv testing done at our clinic. * intention to move from the seattle area within the next year * known allergy, intolerance, or medical contraindication to acyclovir * inability to understand, speak, and read english
effects of non-invasive ventilation with helium-oxygen mixture in premature infants with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome; Premature Infants

Summary: the use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (co2) diffusion coefficient. in previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. the use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (nippv), but knowledge about the effects of such therapy on newborns is limited.the use of non- invasive neurally adjusted ventilatory assist (niv-nava) allows synchronization and assessment of electrical activity of the diaphragm (eadi) during heliox administration in premature babies with respiratory failure.

aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (ga) were enrolled in the study. patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on niv as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. newborns were ventilated with niv nava and standard breathing gas (air-oxygen) at baseline. heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. nava level was kept constant and pulse oximeter oxygen saturation (spo2) kept in range of 90-95%. recorded parameters included heart rate (hr), spo2 and cerebral tissue oxygenation (sto2). selected ventilation parameters: peak inspiratory pressure (pip), positive end-expiratory pressure (peep), mean airway pressure (map), air leakage during niv, fraction of inspired oxygen (fio2) as well as electrical activity of the diaphragm (eadi mean, minimum and maximum) were also acquired. blood gas analysis was performed in each period of the study. statistical analysis was completed with anova friedman's test and single-factor repeated-measures analysis of variance.

Eligibility criteria:
inclusion criteria (group 1): * ga under 33 weeks ga * need for niv due to clinical symptoms of respiratory distress in course of rds * fio2=0.25-0.4 * enrollment within first 72 hours of life * parental consent inclusion criteria (group 2): * ga under 33 weeks ga * need for mv due to clinical symptoms of respiratory distress * at least one failed attempted extubation * parental consent exclusion criteria: * major congenital anomalies * deteriorating pulmonary function despite niv and the need for intubation and conventional mechanical ventilation (cmv) (preliminary criteria: ph\ 65)

Keywords: heliox respiratory distress syndrome (rds) non-invasive ventilation nirs eadi edi niv nava helium-oxygen
standardized patients to measure and address intersectional stigma

Conditions: Hiv; HIV Infections; AIDS

Summary: this study aims to develop and evaluate an intervention to reduce enacted stigma in healthcare settings aimed at people living with hiv (plwh) and men who have sex with men (msm) in china. enacted stigma will be measured using a quality of care score collected through unannounced standardized patient (sp) visits to consenting providers in sexual health clinics.

standardized patients, or trained actors from the community, will conduct a baseline round of unannounced clinic visits with consenting providers for the purposes of observing their clinical performance. sps will present clinically standardized case scenarios, but the hiv status and sexual orientation of each case will be randomly varied in order to quantify the extent to which hiv stigma and/or homophobia contribute to the deterioration of care quality. care quality will be calculated using a global score based on a standard checklist administered to sps following each visit. results of the baseline visit will inform the development of a stigma reduction intervention for consenting providers employed at clinics randomized to the treatment arm of the study. design of this intervention has been informed by results of the baseline study and incorporates expert input from members of community advisory boards (cab), one made up of community members and the other of providers. the intervention will consist of both didactic and skills-building methods and will be delivered both in-person and through follow-up modules online. didactic portions will include content on topics including clinical management of common stis, shared decision making, sexual history taking, and working with marginalized populations. skills-building sessions will include group-based discussion and medical simulation and feedback with trained standardized patients. follow-up data collection will begin within 2 months of completing the stigma reduction intervention using the same approach as for the baseline data collection. all research activities will take place in guangzhou, china.

Eligibility criteria:
inclusion criteria: * eligible facilities will be those with: 1. formal government accreditation as a medical center (a basic tenet of all public hospitals in china); and 2. possession of an accredited on-site laboratory with capacity to provide enzyme-linked immunosorbent assay testing for hiv, treponemal (e.g. treponema pallidum particle agglutination) and non-treponemal tests (e.g. rapid plasma regain) for syphilis. * within eligible and consenting facilities, eligible providers will be those who are licensed at the time of the study to practice dermatovenereology in china. exclusion criteria: * none

Keywords: stigma
long-term efficacy of once daily versus twice daily aspirin in high-risk mpn patients with aspirin resistance

Conditions: Myeloproliferative Neoplasms (MPN)

Summary: patients with myeloproliferative neoplasm (mpn) could have laboratory aspirin resistance and then increasing dose of aspirin from once daily to twice daily regimen is suggested. however, it is not routinely recommended to perform platelet function testing to determine aspirin resistance in mpn patients. moreover, it is not known whether increasing dose of aspirin would always correct aspirin resistance and significantly prevent the thrombotic events in mpn patients. therefore, this study aims to compare the efficacy of once daily versus twice daily aspirin in high-risk mpn patients with aspirin resistance. mpn patients with laboratory aspirin resistance will be included in this prospective randomized study and platelet function testing will be repeated at one and six months later. clinical thrombosis and side effect from aspirin will be recorded for at least 2 years after intervention.

inclusion criteria included adult (\>=18 years) philadelphia-negative mpn patients taking aspirin (81 mg/day). exclusion criteria included concomitant active cancer, thrombocytopenia (platelet less than 50,000/ul), taking anticoagulant, platelet function test (lta method) showing no aspirin resistance, active gastric disease, active bleeding. termination criteria included not taking aspirin regularly, serious side effect from aspirin. block of four randomization is used. lta testing is repeated at month 1 and 6 in both arms. pfa200 method is also done at initial enrollment for comparison with lta method. follow-up outcome data of clinical thrombosis, bleeding complication and adverse events related with aspirin are collected. comparative analysis of outcome data is performed between two arms.

Eligibility criteria:
inclusion criteria: * philadelphia negative myeloproliferative neoplasms aged at least 18 years old exclusion criteria: * concomitant other active malignancy or cured less than 6 months * platelet count less than 50,000/microl * receiving anticoagulant * active peptic ulcer * active bleeding or planning to undergo procedure/operation with bleeding risk * no laboratory aspirin resistance with lta method

Keywords: myeloproliferative neoplasm aspirin resistance
analysis of health status of сomorbid adult patients with covid-19 hospitalised in fourth wave of sars-cov-2 infection

Conditions: COVID-19; Chronic Heart Failure; Diabetes Mellitus; Chronic Kidney Diseases; Ischemic Heart Disease; Arrythmia; Hypertensive Heart Disease; Overweight and Obesity; Oncology; Ischemic Stroke; Myocardial Infarction; Atrial Fibrillation; DVT; Stroke; Copd; Asthma; Pulmonary Embolism; Anemia; Myocarditis

Summary: depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after sars-cov-2 infection in population of eurasian adult patients.

assessment of hospital course and health status during 3, 6, 12 months after discharge in covid-19 patients in cohorts with comorbidities and without comorbidities. evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.

Eligibility criteria:
inclusion criteria: * suspected or confirmed covid-19 exclusion criteria: * age under 18 years. * refusal to be involved in study;

Keywords: covid-19 activ chronic heart failure ischemic heart disease hypertensive heart disease chronic kidney diseases atrial fibrillation myocarditis
expanded access to fosigotifator

Conditions: Vanishing White Matter; Cree Leukoencephalopathy

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to fosigotifator prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme fosigotifator fgt abbv-cls-7262
blood stem cell transplantation for the treatment of older patients with acute myelogenous leukemia

Conditions: Acute Myelogenous Leukemia

Summary: the prognosis for older individuals with acute myelogenous leukemia (aml) has been historically poor, with 2 year disease-free survival rates \ 55 years in age undergoing reduced intensity, transplants from unrelated donors. this study will investigate the safety and efficacy of this treatment option for older patients with aml, with the primary goal being to improve the survival and lifespan for older patients with aml.


Eligibility criteria:
inclusion criteria: for study registration: * age 55 - 70 years. * subjects diagnosed with aml (\> 20% myeloblasts). for proceeding to transplant: * subjects must be in either complete remission (cr) or partial remission (pr) within 14 days prior to admission. * subjects must be \> 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal xrt), prior to admission . * organ function requirements for a reduced intensity (flubu2) regimen (must be met within 21 days of admission): * cardiac: lv ejection fraction \> 40% on muga or echocardiogram. * pulmonary: fev1 and fvc \> 40% predicted, dlco \> 40% of predicted. * renal: serum creatinine \< 2.0 mg/dl. not on hemodialysis or continuous veno-venous filtration (cvvh). * hepatic: serum total bilirubin \< 3.0 mg/dl and ast / alt \< 4x uln * karnofsky \> 60%. * organ function requirements for a full intensity (flubu4) regimen (must be met within 21 days of admission): * cardiac: lv ejection fraction \> 40% on muga or echocardiogram. * pulmonary: fev1 and fvc \> 50% predicted, dlco (corrected for hemoglobin) \> 50% of predicted. * renal: serum creatinine \< 2.0 mg/dl. not on hemodialysis or continuous veno-venous filtration (cvvh) * hepatic: serum total bilirubin \< 3.0 mg/dl and ast / alt \< 4x uln. * karnofsky \> 60%. exclusion criteria: for study registration: * subjects with m3 aml (fab classification) for proceeding to transplant: * subjects who exhibit signs of progressive disease (\> 20% blasts) within 14 days prior to admission for transplant * patients with an uncontrolled viral or fungal infection within the prior 28 days. * patients who are hiv1 or hiv2 positive. * uncontrollable medical or psychiatric disorder

Keywords: aml